Safety and Efficacy of AT-1501 in Patients With IgA Nephropathy (IgAN)

March 25, 2024 updated by: Eledon Pharmaceuticals

A Phase 2a, Multicenter, Open-Label Study to Evaluate the Safety and Efficacy of AT-1501 in Patients With IgA Nephropathy

This is a phase 2a, multicenter, open-label study designed to evaluate the safety and efficacy of AT-1501 in patients with biopsy proven IgAN and at least 0.75 g/24 hours of protein in their urine at the time of screening.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Phase 2a, multicenter, open-label study designed to evaluate the safety and efficacy of AT-1501 in patients with biopsy proven IgAN and at least 0.75 g/24 hours of protein in their urine at the time of Screening. Up to 42 eligible patients will receive one of 2 doses of AT-1501. All patients are scheduled to receive AT-1501 by intravenous infusion every 3 weeks for approximately 2 years.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
    • South Wales
      • Liverpool, South Wales, Australia, NSW 2170
        • Liverpool Hospital
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Monash Medical Centre
      • St Albans, Victoria, Australia
        • Western Health
  • Croatia
      • Zagreb, Croatia
        • University Hospital Centre Sisters of Charity
      • Zagreb, Croatia
        • University Hospital Dubrava Zagreb
  • Malaysia
    • Kuala Lumpur WP
      • Kuala Lumpur, Kuala Lumpur WP, Malaysia, 59100
        • University Malaya Medical Centre (UMMC)
    • Pahang
      • Kuantan, Pahang, Malaysia, 25100
        • Hospital Tengku Ampuan Afzan (HTAA)
    • Sabah
      • Kota Kinabalu, Sabah, Malaysia
        • Hospital Queen Elizabeth
    • Selangor
      • Kajang, Selangor, Malaysia, 43000
        • Hospital Kajang
      • Kajang,, Selangor, Malaysia, 43000
        • Hospital Serdang
  • New Zealand
      • Hamilton, New Zealand, 3204
        • Waikato Hospital
      • Hastings, New Zealand, 4120
        • Hawke's Bay Hospital
  • Philippines
    • Manila
      • Sampaloc, Manila, Philippines
        • University of Santo Tomas Hospital
  • Poland
      • Białystok, Poland
        • Medical University of Bialystok UI
      • Krakow, Poland
        • Specjalistyczne Centrum Medyczne, SCM Spółka
  • Spain
      • Madrid, Spain
        • Hospital Clinico San Carlos
      • Sevilla, Spain
        • Hospital Virgen de la Macarena
      • Zaragoza, Spain
        • Hospital Universitario Miguel Servet
    • Valencia
      • Sagunto, Valencia, Spain
        • Hospital de Sagunto
  • Sri Lanka
      • Colombo, Sri Lanka, 01000
        • National Hospital of Sri Lanka
      • Nugegoda, Sri Lanka, 10250
        • Sri Jayawardanepura General Hospital
  • Thailand
      • Bangkok, Thailand
        • Phramongkutklao Hospital
      • Chiang Mai, Thailand
        • Chiang Mai University
    • Bangkok
      • Dusit, Bangkok, Thailand
        • Prince of Songkla University
      • Pathum Wan, Bangkok, Thailand, 10330
        • Chulalongkorn University
  • United Kingdom
      • Camberwell, United Kingdom
        • Kings College Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Male or female ≥ 18 years of age
  2. Biopsy proven IgAN
  3. Urine protein ≥ 0.75g/24 hours at Screening despite optimization with ACE inhibitors or angiotensin receptor blockers (ARB)
  4. eGFR ≥ 45 mL/min per 1.73 m2 or eGFR < 45 mL/min per 1.73 m2 and ≥ 30 mL/min per 1.73 m2 with a kidney biopsy within 2 years of Screening showing < 50% tubulointerstitial fibrosis
  5. Agree to comply with contraception requirements during and for 90 days after study completion.

Exclusion Criteria:

  1. Any secondary IgAN as defined by the investigator
  2. Patients who have undergone a kidney transplant
  3. Any history of kidney disease other than IgAN
  4. Any history of diabetes (Type 1 or Type 2)
  5. Seated blood pressure > 140 mmHg (systolic) or > 90 mmHg (diastolic) at the Screening Visit. Patients must be on a stable dose and regimen of an ACE inhibitor or ARB for at least 90 days
  6. Pregnancy or breastfeeding.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Arm A
AT-1501 10mg/kg Arm A will receive 10 mg/kg of AT-1501 every 3 weeks for up to 93 weeks for a total of 32 infusions.
Drug: AT-1501
AT-1501 monoclonal antibody targeting CD40L given as an IV infusion
Experimental: Arm B
AT-1501 5mg/kg Arm B will receive 5 mg/kg of AT-1501 every 3 weeks for up to 93 weeks for a total of 32 infusions
Drug: AT-1501
AT-1501 monoclonal antibody targeting CD40L given as an IV infusion

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Efficacy - change in participants UPCR
Time Frame: Up to 24 weeks
The change in 24-hour urine protein to creatinine ratio (UPCR) from baseline to 24 weeks
Up to 24 weeks
Safety- Number of participants with treatment related adverse events
Time Frame: Through study completion, an average of 100 weeks
Incidence of serious adverse events (SAEs), treatment-emergent adverse events (TEAEs), and AEs of special interest (AEoSI)
Through study completion, an average of 100 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in eGFR slope
Time Frame: Baseline- 96 weeks
The change in eGFR slope from baseline to 96 weeks
Baseline- 96 weeks
Change in urine protein excretion (mg/mg)
Time Frame: Up to 96 weeks
The change in urine protein excretion over time
Up to 96 weeks
Development of Anti drug Antibodies (ADAs)
Time Frame: Up to 96 weeks
The percentage of participants who develop ADAs
Up to 96 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Exploratory- Change in baseline serum biomarkers
Time Frame: Through study completion, an average of 100 weeks
The change in serum biomarkers from baseline to completion of study
Through study completion, an average of 100 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eledon Pharmaceuticals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Jeffrey Bornstein, MD, Eledon Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 21, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 8, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 17, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 18, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 26, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 25, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AT-1501-N205
  • 2021-004795-34 (EudraCT Number)
  • U1111-1269-7356 (Other Identifier: Universal Trial Number (UTN))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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